Phase 2
N=37
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
Hypertension Pulmonary Secondary · Heart Failure, Right Sided · Heart Failure With Normal Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT03541603 ↗Enrolled (actual)
37
Serious AEs
10.8%
Results posted
May 2024
Primary outcome: Primary: Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise — -1.9; -0.5 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Levosimendan (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tenax Therapeutics, Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise |
-1.9; -0.5 | — |
| SECONDARY Change in Cardiac Index (CI) at Rest and With Exercise. |
0.05; -0.15; 0.24; 0.04 | — |
| SECONDARY Change in Pulmonary Vascular Resistance (PVR) Effect at Rest and With Exercise |
-0.09; 0.15; -0.44; -0.16 | — |
| SECONDARY Change in PCWP When Supine and Legs Elevated |
-5.1; -1.7; -6.0; -0.3 | — |
| SECONDARY Patient Global Assessment |
3; 3 | — |
| SECONDARY Exercise Duration Via 6 Minute Walk Test |
16.6; -12.8 | — |
| SECONDARY Physician's Assessment of Functional Class |
0; 0; 2; 3; 16; 14 | — |
| SECONDARY Number of Participants With Composite Events of Death or Hospitalization |
3; 1 | — |
Summary
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
Eligibility Criteria
Inclusion Criteria
Criteria to enter Open-label, Lead-in Dose Phase:
- Diagnosis of World Health Organization (WHO) Group 2 Pulmonary Hypertension (PH) with Heart Failure with Preserved Ejection Fraction (HFpEF) confirmed at the time of the diagnosis of pulmonary hypertension.
- Baseline Pulmonary Arterial Pressure (PAP) ≥35, Pulmonary Capillary Wedge Pressure (PCWP) ≥20, New York Heart Association (NYHA) Class IIb/III, Left Ventricular Ejection Fraction (LVEF) ≥40%
- Ability to walk at least 50 meters, but not more than 550 meters in a six-minute walk test.
- Stable oxygen treatment (if applicable), and medications for heart failure, hypertension, and respiratory condition
Criterion for Randomization to Double-blind Phase:
- Response to Open-label, Lead-in Levosimendan: Patients who demonstrate a ≥4mmHg reduction in PCWP from baseline measured at bicycle exercise (25 watts) with no more than a 10% decrease from baseline in cardiac index
Exclusion Criteria
- Subject has a primary diagnosis of PH other than Group 2 PH-HFpEF
- Previous Percutaneous Coronary Intervention (PCI) or cardiac surgery (CABG), unless they have a negative stress test in the last 12 months)
- Congenital heart disease
- Clinically significant lung disease
- Planned heart or lung surgery
- Cardiac Index >4.0 L/min/m2
- Concomitant administration of pulmonary vasodilator therapy or taken within 14 days
- Dialysis or Glomerular Filtration Rate (GFR) 150kg
- Symptomatic systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg
- Heart rate >= 100 bpm with the study drug, symptomatic and persistent for at least 10 minutes
- Hemoglobin 5.5 mmol/L at baseline
- Patients having severely compromised immune function
- Pregnant, suspected to be pregnant, or breast-feeding
Data sourced from ClinicalTrials.gov (NCT03541603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.